SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay

Gas Chromatography, Methamphetamine

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Sefria Methamphetamine Oral Fluid Enzyme Immunoassay.

Pre-market Notification Details

Device IDK203647
510k NumberK203647
Device Name:SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
ClassificationGas Chromatography, Methamphetamine
Applicant Immunalysis Corporation 829 Towne Center Drive Pomona,  CA  91767
ContactWenying (jessica) Zhu
CorrespondentElina Arroyo
Immunalysis Corporation 829 Towne Center Drive Pomona,  CA  91767
Product CodeLAF  
CFR Regulation Number862.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-14
Decision Date2021-12-22

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.